Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
pete
You don't have to go far to find them.
pete...thanks and agree...
Reminds me of Dr. Peter Senge and his work with systems thinking. He is a brilliant guy and a BIG thinker. (ref; Dr. Senge's book, "The Fifth Discipline")
Dr. Senge points to the three levels of knowledge that we all live with.
a. Those things we know , and we know we know them.
b. Those things we do not know, and we know we do not know them.
c. Those things we do not know, and we do not know we do not know them.
I claim that new learning must happen at the interface to the second stage of phase b. . IMO, AVXL staff are now pushing the AD CNS disease knowledge envelope at the level b. science interface. We also must have a lot of people who cannot wait to get a peek at level c. IMO, that is why some are coming aboard AVXL as we speak, while they could go anywhere they want, they must chase level c. (MORE FUN W/DOTS)
My biggest concerns remain in the scale and scope of the concurrent WW CNS diseases trial effort. Multiple-different regulatory country/consideration(s). Multiple CNS indications, w/multiple agencies WW and CRO interfaces. Has anything even close to this complexity ever been attempted...think not.
The good news is, AVXL are rewriting the WW AI-precision med "HOW TO MANUALS" while all the BP's stand around w/open mouths while Dr.M. and team are eating their lunches. (BTW-they-(some) are beginning to see that-IMO.)
The AVXL upstream S1R CNS thesis is taking shape while all others remain in their same ole serial driven hopeless -bottomless pit. WGT. AVXL has already won and the BP ROW does not even know it. Just stand by as they begin to experience their respective AAAAAHHHHAAAA RWE (OH SHAT) respective MOMENTS. It is all beginning to show ....
Why is this not criminal risk to an innocent patient?
STORY AT-A-GLANCE
The U.S. Food and Drug Administration (FDA) granted accelerated approval for the Alzheimer’s disease drug lecanemab (Leqembi)
The drug, a monoclonal antibody, binds to amyloid beta in the brain
The most common reactions included amyloid-related imaging abnormalities, or ARIA, which involves swelling and bleeding in the brain that can be life-threatening. During the trial, ARIA occurred more often in people with the APOE4 gene, which is considered to be the strongest risk factor for Alzheimer’s disease
Amyloid beta may be a symptom of Alzheimer’s — not the cause — and could even have a protective role in the disease process
This means drugs that work by reducing amyloid beta may be missing the problem entirely, putting patients at risk of serious adverse events for little to no benefit
Mercola - FDA Accelerated Approval for Risky Lecanemab, reliance on drugs to reduce amyloid beta may be misguided.
FDA Approves Risky FDA Approves Risky Lecanemab
What happens when the FDA is finally forced to admit that the amyloid Plaque AD causal thesis has not been proven (after 30+ years)? If everyone has to do a mid air restart (or die) ...then what??
We recognize the discipline, process structures and process skills required to manage a regulatory body must continue...but...where will they begin when the AD causal thesis has been finally-totally buried? Will the future be AI-science driven using precision medicine disciplines or will current BP practices keep continue.
“I’m very excited about these 1-year data,” said Remi Barbier, President & CEO. “They add strength and determination to our goal of helping people fight Alzheimer’s disease. Simufilam is an innovative drug candidate that we are developing methodically, one study at a time, and this open-label safety study served its purpose. Next up in 2023 are top-line clinical results of our Cognition Maintenance Study, which is a randomized, controlled trial.”
Not impressed, with this non placebo controlled trial.
Lets all hope this is the start of a legitimate science investigation into the entire Amyloid Plaque scam where trial results do not support the AD claimed Amyloid thesis and yet it was repeatedly allowed to continue as the legitimate causal root . IMO, there is a very dark-deep money pit here.
Not only that new found or verified signals and conditions require re prioritization.
The goal is revenue ASAP!
But is comical how people complain when you don't have a plan.
Then they complain when you have a plan that is dynamic lol-WolofMia
This is great but still in semi-vapor state...cannot wait until RWD/RWE ...BUT.....WHEN hard facts real world examples and data begin to be shown/witnessed (patients-kids doing great things)
proof by examples will dominate the daily WS -SP news....keeping all of that under control will be tough. BUT, nothing we can not handle. We got a tough -smart crew around here sooo, stand by.
Pilots and crews , report to your READY ROOMS. Prepare the flight deck to , "COMMENCE FLIGHT OPERATIONS".
What could possibly go wrong???
The latest Lilly trial results gives a partial explanation..."they ran out of WHAT???"
https://finance.yahoo.com/news/fda-rejects-accelerated-nod-lillys-175205484.html
Avxllent:https://finance.yahoo.com/news/fda-rejects-accelerated-nod-lillys-175205484.html
Beginning to Question When This Happens?
https://finance.yahoo.com/news/fda-rejects-accelerated-nod-lillys-175205484.html
this link-attribution was missed from a msg I posted earlier...my bad.
This pr from today has a few key clues IMO. AVXL is (IMO) competitive in trials w/other international BP.
The AD target market is highly competitive as several other pharma companies like Anavex Life Sciences AVXL, Biogen BIIB and Roche RHHBY have their drugs targeting the AD indication. The Alzheimer’s drugs of these companies have either recently been approved for use or are in late-stage development.
Earlier this month, the FDA approved Biogen/Eisai’s Leqembi (lecanemab) under the accelerated approval pathway for the treatment of early AD. The approval was based on data from a mid-stage study which showed that treatment with the Biogen drug reduced the accumulation of amyloid beta (Aß) plaque in the brain. Biogen/Eisai priced Leqembi at a wholesale acquisition cost (WAC) of $26,500 per year.
Last November, Rocheannounced the failure of the GRADUATE I and II studies, evaluating its monoclonal antibody gantenerumab in early AD. The studies failed to meet their primary endpoint of slowing clinical decline. Patients treated with Roche’s gantenerumab showed a slowdown of clinical decline in GRADUATE I and GRADUATE II, which was not statistically significant. Per Roche, the level of beta-amyloid removal was lower than expected.
Last month, Anavex Life Sciences reported positive topline data from a phase IIb/III study on its lead pipeline candidate ANAVEX 2-73 (blarcamesine) in AD indication. The ANAVEX 2-73-AD-004 study achieved its primary and key secondary endpoints. Data from the study showed that study participants who received ANAVEX 2-73 were 84% more likely to have improved cognition than those who were administered a placebo. Patients treated with ANAVEX 2-73 were 167% more likely to improve function than those receiving a placebo. The treatment also showed a statistically significant reduction in cognitive decline at the end of treatment by 45% compared with the placebo.
A 27% improvement compared to placebo in the CDR SB score at just 48 weeks for Anavex’s blarcamesine is better than EISAI’s/Biogen’s lecanemab at the same time point.
McM...
They have no plaque but they have not stopped the disease.. barely slowing it..
It doesn’t work!...BECAUSE...
The plaque is an outgrowth of the disease
not the disease..
I start my day with the sword at hand, ill lay it down when I die.
"The Pen and the sword, in accord".
What video? Where is the link? Thank you.
After watching tis video I am even more convinced that AVXL upstream S1R model will show important PDD clinical-treatment data and direction for those who suffer w-PD/PDD. IMO, there probably is no CNS silver bullet but getting on the right path starts w/A2-73.
It’s like we are in quiet period until peer review...McM.
Blessings to you as well treden
parks79
preparing data and pushing toward AD and Rett approvals this year to facilitate partnerships and commercialization, in order to fund PD, PDD, Fragile-X and other trials without further dilution.
sokol
If Blarcamesine works well with APOE3 patients, Anavex will focus on those APOE3 patients. This too would be highly significant in seeking approval in Asia. APOE3 is the most common among all human populations. Interestingly, its frequency varies throughout the world. Most interestingly its frequency in Asia seems to be the highest - 85%. ! APOE4 is relatively high in Australia, but highest in Central Africa.
sokol
It will also be interesting to see how the EU regulators may react to Lecanemab given the failure of EU approval of Aduhelm. The EU said in its refusal to approve Adu, along with Adu’s side effects, noted this: “The European Medicines Agency noted that although Aduhelm reduces amyloid beta in the brain, the link between this effect and clinical improvement had not been established.” See: https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-aduhelm-aducanumab_en.pdf
Anaxex has made it explicitly clear they are ready to move from research to commercialization on Alzheimer's disease
basparks79
What's important are the long-term benefits and blarcamesine is showing to be better than lecanecrud... the extension trial will continue to prove that.
Great catch-comment-thx
G328
He’s going to use the existing data to hammer home the point that Anavex is getting closer and closer to
blu_1,
What do you expect on Thursday? This ride has to end somewhere...IMO.
Georgejji
Less than 24 hours until GREAT NEWS for AVXL
We need and expect a best effort by all.
NEW YORK, Dec. 12, 2022 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that it will present at the 41st Annual J.P. Morgan Healthcare Conference on Thursday, January 12th 2023, at the Westin St. Francis in San Francisco, CA. Christopher U Missling, PhD, President & Chief Executive Officer will present the Company in a session scheduled 08:15 AM - 08:55 AM (Pacific Time).
A live audio webcast will be accessible through the Investors section of the Company’s website at www.anavex.com. An archived edition of the session will be available later that day.
Tom Bishop ...good read...accurate, timely
Anavex (AVXL), is a biopharmaceutical company dedicated to the development of novel drug candidates to treat central nervous system diseases with very encouraging results so far in Alzheimer’s, Parkinson’s and Rett Syndrome.
The big news for Anavex was the release of the preliminary data from the 508 patient, placebo controlled, double-blind, 48-week, Phase 2b/3 ANAVEX 2-73 (blarcamesine or A2-73) Alzheimer’s trial which tested 3 equal cohorts with placebo, 30 mg or 50 mg oral doses.
First I need to point out two very important things:
1) There was a delay in getting the data from one of the trial sites that resulted in the company only getting the data from the third party statistical analysis company just 1 day before it was on the schedule to present at the CTAD Alzheimer’s conference. This therefore limited what the company could accurately report at that time.
2) Some of the best results from an earlier trial were for the 50 mg. cohort, while the 30 mg barely worked. However, ALL of the analysis presented recently was for the combined 30+50 mg patients as a single cohort, diluting the efficacy results.
Therefore, results yet to come should be even better once the company reports on the 50 mg cohort by itself. The primary endpoints were the reduction in the decline of cognition (ADAS-COG) and activities of daily living (ADCS-ADL) at 48 weeks.
On this the company said, “The Anavex 2-73 (blarcamesine) study met the primary and key secondary endpoints showing statistically significant reduction of clinical decline in global cognitive and functional scales in a clinical study of patients with early Alzheimer’s disease.” (MMSE baseline scores 20-28).
And more to the point: “Treatment with ANAVEX®2-73 statistically significantly reduced cognitive decline, measured with ADAS-Cog, compared to placebo at end of treatment by 45% (p=0.033).”
This is the most significant and directly on point outcome released so far for this trial given this was considerably better than BiogenBIIB +1.9%/Eisai’s 27% slowing of cognitive decline recently reported for lecanemab.
Nonetheless lecanemab's meager result caused those two companies to increase $20 billion in market cap overnight. Most observers believe this Phase 3 result paves the way for likely FDA approval. However, Anavex’s drug beat lecanemab by a wide margin (a 45% slowing vs. 27%) in its Phase2b/3 trial.
But here’s the thing … Biogen’s drug requires IV infusion therapy and periodic MRIs to check for brain swelling and bleeding (two nasty side effects of lecanemab), while A2-73 is a pill and doesn’t require periodic MRI’s, a huge advantage even ignoring that A2-73 worked better.
While the data already released was superior to lecanemab, once the 50 mg alone cohort data comes out the results should be considerably better than for the combined group. And better still for just those 85% carrying the normal SigmaR1 gene as well as for APOE2 and 3 patients. (Still a big target market.) So I think the data so far was encouraging, but the best news is yet to come — and the stock remains a favorite for 2023.
Very positive : https://www.forbes.com/sites/moneyshow/2023/01/09/6-favorite-biotech-bets-for-2023/?sh=2e7d28e28ae5
WOW...the pot is starting to steam a little. Soon to be boiling hot....
What happens next?
Do we get a (maybe-probably- someday) package or do we hit a grand slam?
Obviously there is a lot more at stake here than just one more CNS diseases trial. This is a systems event.
IMO, this is for all the marbles played for the last 30+ years by the combined systems. (Insurance co.'s, medical device product producers of MRI and every type of combination techs, the whole memory care industry, the clinics for infusions, home care industries, WS, etc.. The entire line of Amyloid (read uncertainty )driven healthcare clinics and practices...the list goes on.
Future direction for BP investment plans could all be decided by simple-direct AVXL trial results. Are we about to disambiguate the stack? There are a lot of stacked interest in the status quo crowd who kinda like things as they are right now. Lots of money on the table. IMO, strong trial results from AVXL will point to WS uncertainty in certain investment areas .
AVXL, needs a solid walk-off victory kind of session. In fact, maybe WS has not seen such an event and all the brilliant-money people have to rethink some plans. We'll see. Those folks who stir up and thrive on uncertainty to make a living must hate this kind of drama.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269s000lbl.pdf
Apparently the FDA without an advisory group of physicians did NOT consider all of the trials and all of the data BEFORE making their decision.
crescent? Any insights (biostat source) on AVXL-OLE PDD results? TIA.
Very shortly an independent biostat firm will report out how many of the 200 patients in SAVA's OLE trial demonstrated some cognitive improvement (not just an improvement in decline in ADAS-COG scores after a year's Simufilam dosing.
All anyone needs to know. Ever wonder why they even have this conversation?
HOW DOES THE NEW DRUG WORK?
https://apnews.com/article/health-medication-b42dc8b32d71f1b6892b07d85e0e7da0
The drug, made by Japan’s Eisai and its U.S. partner Biogen, is designed to target and clear away a sticky protein called beta-amyloid that builds up into brain-clogging plaques -- one key hallmark of Alzheimer’s disease.
It’s a long-needed new treatment, but experts also are voicing a lot of caution: The drug isn’t a cure, it’s only intended for early-stage patients, requires IV doses every two weeks, and comes with some safety concerns.
IMO, AVXL must present multiple RWE/RWD clinical trial cases. These should be realistic, verifiable, convincing factual summations linked w/human results from the AVXL treatments. I have long believed the RSD cases would provide strong evidence of (Before-After) credible and medically demonstrative change tied to treatments. Prove we have the truth and move on w/o fear.
The liars and the thieves must be outed.
Corruption may involve many activities which include bribery, influence peddling and the embezzlement and it may also involve practices which are legal in many countries. Political corruption occurs when an office-holder or other governmental employee acts with an official capacity for personal gain.
Corruption - Wikipediahttps://en.wikipedia.org › wiki › Corruption
AN "AHHHAAA" moment: thx again from XENA
A doctor speaks about the approval process for Alzheimer's drugs...
https://www.facebook.com/DrScottJensen/videos/2518157701675288
Xena...WOW...Thanks.
Xena
A doctor speaks about the approval process for Alzheimer's drugs...
https://www.facebook.com/DrScottJensen/videos/2518157701675288
crescentmotor
Yes--but my point was centered on in what regulatory juridiction(s) should AVXL initially file for drug approval. It may well be that some jurisdictions may facilitate/hasten the regulatory approval process whereas other jurisidictions may, for whatever reason, throw up delays or even roadblocks. AVXL needs to test the water temperature before making the huge, time-consuming commitments that will be required. I am actually hoping the release of full data will trigger action by one or more of the regulatory jurisdictions.